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510(k) Data Aggregation

    K Number
    K040726
    Device Name
    VENTLAB NASAL CPAP CANNULA
    Manufacturer
    VENTLAB CORP.
    Date Cleared
    2004-06-03

    (73 days)

    Product Code
    BZD
    Regulation Number
    868.5905
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    VENTLAB NASAL CPAP CANNULA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Ventlab Nasal CPAP Cannula is an accessory to positive pressure ventilation devices for patients suffering from Obstructive Sleep Apnea requiring positive airway pressure therapy (i.e., CPAP, BiLevel).

    Device Description

    Ventlab Nasal CPAP Cannula

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a medical device called the "Ventlab Nasal CPAP Cannula." It indicates that the device has been found substantially equivalent to legally marketed predicate devices.

    However, the provided text does not contain any information regarding acceptance criteria, device performance results, sample sizes for testing or training, ground truth establishment, or details about any studies conducted (like MRMC or standalone studies).

    Therefore, I cannot fulfill your request for this information from the provided document. The document primarily focuses on the regulatory clearance process and includes an "Indications for Use" statement, but no technical study details.

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